FDA Registration
Active
🇺🇸 United States
Vessel Shunt, 1.25mm Tip,12mm Shaft
Reg #: 1649139
·
FEI: 3002406063
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- KDL MEDICAL, INC.
- Registration Number
- 1649139
- FEI Number
- 3002406063
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 800 E Campbell Rd Ste 252
- City
- RICHARDSON
- State
- TX
- ZIP
- 75081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K972665
Owner / Operator
- Firm Name
- KDL MEDICAL, INC. dba CHASE MEDICAL
- Operator Number
- 9028011
- Address
- 800 E. Campbell Rd., Suite 252
- City
- Richardson
- State
- TX
- Postal Code
- 75081
- Country
- US
- Correspondent
- JACKIE LAFOLLETTE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2008-03-19 |
Proprietary Names
Vessel Shunt, 1.25mm Tip,12mm Shaft
Vessel Shunt, 2.5mm Tip,12mm Shaft
Vessel Shunt, 3mm Plug, 30mm Shaft
Vessel Shunt, 1.5mm Tip,12mm Shaft
Vessel Shunt, 3mm Plug,12mm Shaft
Vessel Shunt, 1.75mm Tip,12mm Shaft
Vessel Shunt, 10mm Tip,12mm Shaft
Vessel Shunt, 2mm Plug, 30mm Shaft
Vessel Shunt, 2.5mm Plug, 30mm Shaft
Vessel Shunt, 4mm Plug, 30mm Shaft
Vessel Shunt, 2mm Tip,12mm Shaft
Vessel Shunt, 4mm Plug,12mm Shaft
Vessel Shunt, 2.25mm Tip, 12mm Shaft
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198